The following data is part of a premarket notification filed by Jpi Healthcare Solutions, Inc with the FDA for Exam Vue Pacs.
| Device ID | K162868 |
| 510k Number | K162868 |
| Device Name: | Exam Vue PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | JPI Healthcare Solutions, Inc Woolim E-Biz Center #608, 170-5 Kuro 3-dong, Kuro_gu, KR 152-769 |
| Contact | Jang Won Lee |
| Correspondent | William Little JPI Healthcare Solutions, Inc 52 Newtown Plaza Plainview, NY 11803 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-13 |
| Decision Date | 2017-03-17 |
| Summary: | summary |